FDA Launches New Quality/Compliance Web Content

FDA's Office of Compliance and Biologics Quality (QCBQ) within the Center for Biologics Evaluation and Research (CBER) has launched a web page describing responsibilities such as inspection, surveillance, and compliance to pre- and post- market approval activities.

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Public Review until April 21: Proposed Confirmation of Two IQPP Standards +
The following proposed actions are hereby opened for public review:
- Confirmation (continued implementation) of Version 3.0 of the IQPP Cross Donation Management Standard
- Confirmation (continued implementation) of Version 1.0 of the IQPP Donor Fluid Administration Standard
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PPTA encourages EDQM to take a patient-centric approach in the implementation of its Plasma Supply Management Recommendations +

The European Commission and the European Directorate for the Quality of Medicines (EDQM) recently published recommendations on plasma supply management in Europe. The recommendations were drafted by a working group of transfusion specialists representing national blood services (also called the TS093 working group). PPTA thanks the EDQM and the European Commission for addressing this important issue but is concerned that the recommendations do not go far enough towards ensuring the collection of sufficient plasma to meet the growing clinical need for plasma-derived medicinal products (PDMPs).
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New Coronavirus (SARS-CoV-2) and Plasma Protein Therapies (updated February 17, 2020) +

Recent international reports have highlighted the emergence of a new coronavirus in Wuhan, Hubei Province, China (1). The 2019 Novel Coronavirus (2019-noCoV), now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified by Chinese authorities in December 2019 and since then has been associated with pneumonia in over 70,000 persons in China and more than 1,700 deaths (1-3). *
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FDA Launches New Quality/Compliance Web Content

Public Review until April 21: Proposed Confirmation of Two IQPP Standards +

PPTA encourages EDQM to take a patient-centric approach in the implementation of its Plasma Supply Management Recommendations +

New Coronavirus (SARS-CoV-2) and Plasma Protein Therapies (updated February 17, 2020) +

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